Abdominal Wall Closure With Triclosan-coated Suture (TCS09)

This study has been completed.
Sponsor:
Information provided by:
University of Pecs
ClinicalTrials.gov Identifier:
NCT01620294
First received: May 10, 2010
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

After open colorectal surgery the surgical site infection (SSI) is very high among abdominal surgeries. The goal of the investigators randomized, prospective, multicentric, internet-based study is to compare rate of SSI after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. 180-180 cases in seven centres are involved in this study. Two arms are separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS versus PDS-Plus). Triclosan is an antiseptic material which the investigators hope will provide better local infection control at the site with reducing the risk of bacterial colonisation.


Condition Intervention Phase
Infection
Procedure: abdominal wall closure
Procedure: surgical site infection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Abdomen Closure Using Triclosan Coated Absorbable Suture vs Uncoated Sutures of the Same Base Material

Resource links provided by NLM:


Further study details as provided by University of Pecs:

Primary Outcome Measures:
  • quality and quantity of wound discharge [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of applied different types of bandages [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • charges of wound care [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: November 2009
Study Completion Date: November 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: triclosan
Two arms are separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).
Procedure: abdominal wall closure
triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall
Other Names:
  • presence of surgical site infection
  • level of surgical site infection
Experimental: uncoated
Two arms are separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus).
Procedure: surgical site infection
triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall
Other Names:
  • presence of surgical site infection
  • level of surgical site infection

Detailed Description:

After open colorectal surgery the surgical site infection (SSI) is very high among abdominal surgeries. The goal of our randomized, prospective, multicentric, internet-based study is to compare rate of SSI after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. Two arms are separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS versus PDS-Plus). Triclosan is an antiseptic material which we hope provides better local infection control at the site with reducing the risk of bacterial colonisation.

attached website: www.itplan.hu/sebstudy/ Randomizing patients: 1. logging in (completing the ID panel) 2. on-line randomization 3. patient appears on list 4. operation (recording details) 5. recording - post-operation events

  • complications
  • control examination
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective (subjected to bowel preparation) operations
  • Benign or malignant colon or rectal disease
  • Age: 18-80
  • Bowel opening is made during operation

Exclusion Criteria:

  1. Cannot be randomized:

    • Systemic diseases influencing local surgical site healing
    • Insulin-dependent diabetes mellitus
    • Child B-C liver cirrhosis
    • Kidney disease requiring dialysis
    • Immune-suppression treatment
    • IBD
    • Acute surgery or unprepared bowel
    • After being informed patient does not sign the statement of consent
  2. To be excluded later:

    • Surgically incurable tumour
    • Septic state or complication occurred in the post-operational stage
    • Patient withdraws the signed consent before the examination is closed
  3. Undesirable complication:

    • Sterile surgical site separation
    • Suture break during the post-operational stage
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620294

Locations
Hungary
Department of Surgery Medical Faculty, University of Pecs, Hungary
Pecs, Hungary, 7624
Sponsors and Collaborators
University of Pecs
Investigators
Principal Investigator: Ors Peter Horvath, MD, PhD, DSc Head of Surg.Dept. Univ. of Pecs, Hungary - ophorvath@iseb.pote.hu
  More Information

Additional Information:
Publications:

Responsible Party: Medical Center, University of Pecs, Prof. O P Horvath MD, PhD.ScD
ClinicalTrials.gov Identifier: NCT01620294     History of Changes
Other Study ID Numbers: triclosan-coated-suture2009
Study First Received: May 10, 2010
Last Updated: June 14, 2012
Health Authority: Hungary: Institutional Ethics Committee

Keywords provided by University of Pecs:
surgical site infection
elective colorectal surgery
level of surgical site infection
complication of surgical site infection
type of changed bandage
frequency of bandage changing

Additional relevant MeSH terms:
Triclosan
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 31, 2014